Phase 3
N=60
To Access the Effects of Mucositis in Adults With Dental Implants
Mucositis
Bottom Line
View on ClinicalTrials.gov: NCT01072201 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcome: Primary: Bleeding on Probing — 53.8; 52.3 Percentage of bleeding sites — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Triclosan and Fluoride (Drug); Fluoride (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bleeding on Probing |
53.8; 52.3 | 0.05 |
| PRIMARY Mean Pocket Depth |
4.4; 4.5 | 0.05 |
| PRIMARY Mean Percentage of Plaque Scores |
13.2; 16.0 | 0.05 |
Summary
Clinical research for the treatment of mucositis subjects who have dental implants for a minimum of one-year.
Eligibility Criteria
Inclusion Criteria
- Male and female subjects, ages 30-70.
- Availability for the six-month duration of the clinical research study.
- Good general health.
- Subjects who have lost teeth for periodontal disease reasons and who have been restored with implants.
- Minimum of 5 remaining teeth and a minimum of 2 implants.
- Initial evaluation of the gingival and peri-implant mucosal tissues by determining full mouth bleeding on probing.
- Initial plaque evaluation by determining full mouth presence/absence of plaque.
- Signed Informed Consent Form.
Exclusion Criteria
- Tumor(s) of the soft or hard tissues of the oral cavity.
- Untreated periodontal disease (purulent exudate, tooth mobility, and/or extensive loss or periodontal attachment or alveolar bone).
- Carious lesions requiring immediate restorative treatment.
- Uncontrolled Diabetes
- Use of antibiotics any time during the one month prior to entry into the study.
- Untreated peri-implantitis.
- Participation in any other clinical research study or test panel within the three months prior to entry into the study.
- Pregnant women or women who are breast feeding.
- History of allergies to personal care/consumer products or their ingredients.
- Medical condition which prohibits not eating/drinking for up to 2 hours.
- Current alcohol or drug abuse.
- Systemic or local disease conditions that would compromise post-operative healing.
- Regular use of anti-inflammatory drugs.
Data sourced from ClinicalTrials.gov (NCT01072201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.